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Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
NCT04697628 · View on ClinicalTrials.gov ↗
Study Summary
This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.
Conditions Studied
Interventions
- DRUG gemcitabine
- DRUG vinorelbine
- DRUG topotecan
- DRUG tisotumab vedotin
- DRUG irinotecan
Study Locations (20)
Kentucky
- Norton Cancer Institute, Downtown — Louisville
- Norton Hospital — Louisville
- Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD — Louisville
- Norton Cancer Institute, St. Matthews Campus — Louisville
- Norton Cancer Institute — Louisville
- Norton Women's & Children's Hospital — Louisville
Arizona
- Arizona Oncology Associates, PC - HAL — Glendale
- Arizona Oncology Associates P.C. - NAHOA — Phoenix
- Arizona Oncology Associates, PC - HAL — Phoenix
- Arizona Oncology Associates, PC - HAL — Scottsdale
- Arizona Oncology Associates, PC - HAL — Tempe
California
- University of California Irvine Health — Irvine
- UC Irvine Health (Investigator Site File Location) — Orange
- University of California Irvine Health — Orange
- Olive View - UCLA Medical Center — Sylmar
Illinois
- Northwestern Medical Group — Chicago
- Northwestern Memorial Hospital — Chicago
Connecticut
- Yale University School of Medicine — New Haven
Florida
- Broward Health Medical Center — Fort Lauderdale
Georgia
- Georgia Cancer Center at Augusta University — Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2026-01-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04697628
The ClinicalTrials.gov registry entry for NCT04697628 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 502 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cervical Cancer appearing as the primary indexed condition, and to 5 interventions — of which gemcitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04697628 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Kentucky, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04697628 about?
NCT04697628 is a clinical study titled "Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer". This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will...
What is the current status of trial NCT04697628?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 502 participants. The study started on 2021-02-22. Estimated completion is 2026-01-15.
What conditions does trial NCT04697628 study?
This clinical trial studies the following conditions: Cervical Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04697628?
The interventions under investigation include: gemcitabine (DRUG), vinorelbine (DRUG), topotecan (DRUG), tisotumab vedotin (DRUG), irinotecan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04697628?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04697628 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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